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Novocastra

FDA UDI

Class I (US FDA UDI)

by Leica Biosystems Newcastle, Limited

Identity

Trade Name
Novocastra FDA UDI
Generic Name
Human herpesvirus 8 (HHV8) antigen IVD, antibody FDA UDI
Device Name
NCL-L-HHV8-LNA-U is intended for the qualitative identification by light microscopy of Human Herpesvirus (Type 8) (latent nuclear antigen) in parrafin sections. FDA UDI
Model / Reference
HHV8-LNA-L-U FDA UDI
Description
NCL-L-HHV8-LNA-U is intended for the qualitative identification by light microscopy of Human Herpesvirus (Type 8) (latent nuclear antigen) in parrafin sections. FDA UDI

Identifiers

Catalog Number
NCL-L-HHV8-LNA-U FDA UDI
Primary DI / UDI-DI
05055331333810 FDA UDI
FDA Product Code
NJT FDA UDI
GMDN Term
Human herpesvirus 8 (HHV8) antigen IVD, antibody FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.1860 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Human herpesvirus 8 (HHV8) antigen IVD, antibody

Novocastra by Leica Biosystems Newcastle, Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Human herpesvirus 8 (HHV8) antigen IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Leica Biosystems Newcastle, Limited

Sources (1)

  • FDA UDI 0d330d4b-77aa-4856-95a5-4eb73fdbcd96 36 fields · synced May 30, 2026